NCT07225647已完成1 期
An Open-Label, Randomized, Two-part Study in Healthy Participants to Assess the Food Effect on the Pharmacokinetics of Admilparant To-Be-Marketed Tablet Formulations
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年11月7日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the effect of food on the drug levels of Admilparant
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- •Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.
排除标准
- •Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- •Participants must not have had any previous exposure to Admilparant.
- •Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity).
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 1: Treatment A
Experimental
干预措施: Admilparant (Drug)
Part 1: Treatment B
Experimental
干预措施: Admilparant (Drug)
Part 2: Treatment C
Experimental
干预措施: Admilparant (Drug)
Part 2: Treatment D
Experimental
干预措施: Admilparant (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 13 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to 13 days
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to 13 days
次要结局
- Apparent total body clearance (CLT/F)(Up to 13 days)
- Apparent volume of distribution (Vz/F)(Up to 13 days)
- Terminal half-life (T-HALF)(Up to 13 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 13 days)
- Number of participants with adverse events (AEs)(Up to 13 days)
- Number of participants with a change in clinical laboratory values(Up to 13 days)
- Number of participants with a change in vital sign measurements(Up to 13 days)
- Number of participants with a change in physical examination results(Up to 13 days)
- Number of participants with a change in 12-lead electrocardiogram (ECG) results(Up to 13 days)
研究者
研究点 (2)
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